Tens of millions of doses of AstraZeneca’s coronavirus vaccine are currently sitting in U.S. distribution centers. The company is awaiting results from its U.S. clinical trial before requesting emergency use authorization from the Food and Drug Administration.
Made by the British-Swedish drugmaker AstraZeneca in collaboration with Oxford University, the vaccine has been causing controversy in some European countries over fears that it has links to blood clots.
On Monday its rollout was suspended in Germany, France and Italy after reports that four people in Norway had been hospitalized with clotting after receiving the inoculation. Other countries in the region, including Denmark, Bulgaria, Iceland and Norway, temporarily halted its use on March 11. Austria suspended the use of certain batches of the drug while its health authorities investigate.
Is the AstraZeneca vaccine safe?
There is currently no cause for concern over the side effects of the AstraZeneca vaccine, health experts say.
Dr. Kavita Patel, a Yahoo News Medical Contributor, said: “It’s actually very puzzling to many of us in the medical and scientific community about the halting of use of the AstraZeneca vaccine in several countries.
“That is because the cases and the rates of blood clotting events — pulmonary clots, clots in the veins of the legs — are not seen at any frequency higher than in people who did not get the vaccine.”
Many countries pausing the rollout say they are doing so as a precaution following reports of blood clots in some recipients.
The European Medicines Agency (EMA) stressed that there is no indication that the events are linked to the vaccination.
The EMA’s executive director, Emer Cooke, said on Monday: “While the investigation is ongoing, currently we are still firmly convinced that the benefits of the AstraZeneca vaccine in preventing COVID-19, with its associated risk of hospitalization and death, outweigh the risks of these side effects.”
On Monday, a World Health Organization spokesperson also said they found “no evidence” that the incidents were linked to the vaccine.
“As soon as WHO has gained a full understanding of these events, the findings and any unlikely changes to current recommendations will be immediately communicated to the public,” WHO spokesman Christian Lindmeier said.
The WHO is meeting with vaccine safety experts on Tuesday to review the developments.
AstraZeneca addressed the concerns on Sunday and said a review of safety data of people inoculated with its COVID-19 vaccine has shown no evidence of an increased risk of blood clots.
Has the AstraZeneca vaccine been authorized for use in the U.S.?
AstraZeneca has not yet filed for emergency use authorization in the U.S., but could do so as soon as late March, according to a report by Reuters. In February, the drugmaker said it could immediately provide 30 million doses to locations across the United States if the vaccine is approved in early April.
In January, the company began conducting a phase III trial on more than 32,000 volunteers in the U.S. The results of the study could help answer safety questions over the reports of blood clots in some vaccine recipients.
Elsewhere, the vaccine has been approved by government regulators and distributed widely.
The U.K. has administered millions of doses to its citizens — in what has been one of the fastest single-dose vaccine campaigns in the world. According to Oxford University’s Our World in Data research, more than 26 million people have received at least one dose of a coronavirus vaccine so far in the U.K., where vaccines from both Pfizer and AstraZeneca have been authorized for use.
Is the AstraZeneca vaccine as good as the other already approved vaccines?
Data released by the U.K. government shows that the AstraZeneca vaccine is highly protective against serious COVID-19, reducing the chance of someone getting ill and needing hospital treatment by more than 80 percent.
Patel said it’s hard to compare the current vaccines available in the U.S. without the American data from AstraZeneca.
However, “the benefit is that the data will be published, fully reviewed by the FDA and then also reviewed by the CDC, which will give advice on who should be given the vaccine,” she explained.
“But looking at the data so far from other countries, it’s very similar to what we see with the currently authorized vaccines in the United States,” Patel added.
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